TOTAL CHOLESTEROL TEST KIT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-08 for TOTAL CHOLESTEROL TEST KIT * manufactured by Biosafe Diagnostic Products, Inc..

Event Text Entries

[242521] The ebiosafe cholesterol kit is labeled as "ouchless" and "painless" this is a misrepresentation. The lancet they use is not ouchless or painless.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1024125
MDR Report Key378364
Date Received2002-02-08
Date of Report2002-02-08
Date Added to Maude2002-02-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameTOTAL CHOLESTEROL TEST KIT
Generic NameCHOLESTEROL TEST
Product CodeNFX
Date Received2002-02-08
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key367403
ManufacturerBIOSAFE DIAGNOSTIC PRODUCTS, INC.
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2002-02-08

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